OncoMatch/Clinical Trials/NCT07428707
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Is NCT07428707 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Pirtobrutinib for chronic lymphocytic leukemia (cll).
Treatment: Pirtobrutinib — Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Lab requirements
Blood counts
Hemoglobin >= 8 g/dL (>= 80 g/L); ANC >= 0.75 x 10^9/L; Platelets >= 50 x 10^9/L; Hgb and platelets: independent of transfusions within 7 days of Screening assessment. ANC: independent of growth factor support within 7 days of Screening assessment.
Kidney function
Serum creatinine: Calculated creatinine clearance >= 30 ml/min according to Cockcroft/Gault Formula
Liver function
ALT or AST <= 3 x ULN or <= 5 x ULN with documented liver involvement; Total bilirubin <= 1.5 x ULN or <= 3 x ULN with documented liver involvement and/or Gilbert's Disease
adequate organ function for all of the following criteria, as defined below: Hepatic: ALT or AST <= 3 x ULN or <= 5 x ULN with documented liver involvement; Total bilirubin <= 1.5 x ULN or <= 3 x ULN with documented liver involvement and/or Gilbert s Disease. Renal: Serum creatinine: Calculated creatinine clearance >= 30 ml/min according to Cockcroft/Gault Formula. Hematologic: Hemoglobin >= 8 g/dL (>= 80 g/L); ANC >= 0.75 x 10^9/L; Platelets >= 50 x 10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07428707 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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